An interventional study of LETS ACT and LETS ACT-SE in Substance-Related Disorders, Depressive Disorder and Behavioral Symptoms, sponsored by University of North Carolina, Chapel Hill. Completed at 2 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
The purpose of this study is to:
Comorbid substance use disorder (SUD) and depression is highly prevalent and associated with elevated rates of post treatment relapse to substance use, HIV risk behavior, and associated poor mental and physical health outcomes. Further, rates of substance use and depression disproportionately affect minority groups and those living in poverty. Although efficacious, the often complex, specialized nature of CBT poses problems in its integration into substance use treatment programs. Budget cuts for mental health and substance use treatment both nationally and in the state of North Carolina, reduce availability of publically funded treatment programs and staff to patient ratios. To address this limitation, a behavioral activation (BA) treatment, the Life Enhancement Treatment for Substance Use (LETS ACT), was developed to treat depressive symptoms among a predominantly African American sample of low income illicit drug users currently receiving residential substance use treatment. Collectively, two Stage I studies and 1 year follow-up data from the investigators Stage II R01DA026424 indicate that compared to a control condition, LETS ACT is associated with significantly better outcomes for treatment retention, post treatment abstinence, HIV sexual risk behavior, depressive symptoms, and environmental reward.
Although these strong outcomes suggest that LETS ACT may be ready for a Stage III dissemination trial, it is of note that there was a significant indirect effect of LETS ACT homework compliance on post treatment substance use and HIV sexual risk behavior via the theoretically proposed BA mechanism of action, environmental reward. In the context of limited access to care, these findings point to the need to identify cost-effective delivery-vehicles to increase treatment engagement outside of clinician sessions. Further, identifying neuroscience based biomarkers (neuromarkers) underlying key theoretical aspects of BA (i.e., reward sensitivity), and their relation to heterogeneity in BA treatment response among substance users with depression, are critical for the identification of accurately targeted interventions.
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Exclusion Criteria:
Patients are offered substance use group therapy including relapse prevention. They are also provided medical consultation on an ongoing basis as needed.
Behavioral: Treatment as Usual
The Life Enhancement Treatment for Substance Use (LETS ACT) involves the discussion of the treatment rationale, identification of values and goals in various life areas and activities in line with chosen life areas, and training for patients to identify their cycle of negative mood and behavior using forms to track their daily goals.
Behavioral: LETS ACT · Behavioral: Treatment as Usual
Participants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.
Behavioral: LETS ACT-SE · Behavioral: Treatment as Usual
The Life Enhancement Treatment for Substance Use (LETS ACT)
Also known as: Behavioral Activation, Life Enhancement Treatment for Substance Use
Participants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.
Also known as: Behavioral Activation, Smartphone-Enhanced LETS ACT
Participants will receive the treatment typically provided to patients at the substance use treatment facility.
Also known as: TAU
Timeline Followback (TLFB)
The Time Line Follow Back is a self-report measure of drug and alcohol use.
Time frame: TLFB will be assessed from baseline to a 12-month follow up period.
Behavioral Activation for Depression Scale (BADS)
The BADS is a 25-item self-report measure of overall level of activity involvement
Time frame: BADS will be assessed from baseline to a 12-month follow up period.
Reward Probability Index (RPI)
The RPI is a 20-item self-report measure used to assess environmental reward and punishment.
Time frame: RPI will be assessed from baseline to a 12-month follow up period.
Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms
Time frame: BDI-II will be evaluated from baseline to a 12-month follow up period
Daily Goals Form
The Daily Goals Form is used to measure Treatment Engagement.
Time frame: Baseline to a 3-months post treatment.
Texas Christian University (TCU) HIV/AIDS Risk Assessment Form
The TCU is a self-structured interview that measures HIV risk behavior in the domains of drug use and sex
Time frame: TCU will be assessed from baseline to a 12-month follow up period.
Urinalysis
Urinalysis is a biological measure of substance use.
Time frame: Urinalysis is assessed from post treatment to a 12-month follow up period
Breathalyzer
Breathalyzer is a biological measure of alcohol use.
Time frame: Breathalyzer will be assessed from baseline to a 12-month follow up period.
Short Form Health Survey (SF-12)
The SF-12 is a 12-item self-report measure of mental and physical health-related functioning.
Time frame: SF-12 will be assessed from baseline to a 12-month follow up period.
Plan to share: No
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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